- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05781477
Effect of Breastfeeding Training Program and System (BMUM) for Mothers
March 10, 2023 updated by: Şahika ŞİMŞEK ÇETİNKAYA, Kastamonu University
Effect of Breastfeeding Training Program and Nurse-led Breastfeeding Online Counselling System (BMUM) for Mothers: Randomized Controlled Study
The goal of the study was to investigate effect of breastfeeding training program and nurse-led breastfeeding online counselling system (BMUM) on mothers' breastfeeding self-efficacy, breastfeeding attitudes, breastfeeding problems and postpartum depression we hypothesized that there would be differences between BG and CG groups in terms of breastfeeding self-efficacy, breastfeeding problems, postpartum depression and breastfeeding frequency.
This was a randomized controlled trial.
Participants were randomly assigned to the breastfeeding group (BG; n = 36), or control group (CG; n = 36).
Control group will receive only standart care breastfeeding group will receive standart care and web based breastfeeding support.
Breastfeeding attitudes, infant feeding attitude breastfeeding problems and postpartum depression will assessment.
The assesment point will be 32-37 gestational week, postpartum 1st day, 1st week, 3 months, and 6 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kastamonu
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Merkez, Kastamonu, Turkey, 37150
- Şahika Şimşek Çetinkaya
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Merkez, Kastamonu, Turkey, 37150
- Kastamonu University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 18-35 years old,
- Primipara with a singleton pregnancy
- 32- and 37-weeks of gestation,
- Willingness to participate in the workshop program
Exclusion Criteria:
- Having a chronic illness
- Having pre-term labor or an abnormal fetal screening
- Had a psychiatric disorder or anxiety disorder
- Having any other high-risk complications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bmum GROUP
Mothers in this group were given supportive breastfeeding support with web based
|
Bmum is a web-based online tracking system that aims to improve positive attitude about breastfeeding
|
No Intervention: control group
Mothers in the control and intervention groups were given standard care based on the Baby-Friendly Hospital Intervention Standard.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding Self efficacy change on five points between groups
Time Frame: 32-37 weeks 1st. day 1. week 3rd months 6th months
|
Breastfeeding Self efficacy short form scale will use to assessment breasfeeding self efficacy.
Total scores vary from 14 to 70, with higher scores indicating greater self-efficacy
|
32-37 weeks 1st. day 1. week 3rd months 6th months
|
Infant feeding attitude change on five points between groups
Time Frame: 32-37 weeks 1st. day 1. week 3rd months 6th months
|
Iowa Infant Feeding Attitude Scale (IIFAS) will use to assessment infant feeding attitude Higher scores indicate a more favorable attitude toward newborn feeding
|
32-37 weeks 1st. day 1. week 3rd months 6th months
|
Postpartum depression change on four points between groups.
Time Frame: 1st. day 1st. week 3rd months 6th months
|
Edinburgh Postnatal Depression Scale (EPDS) will use to assesment postpartum depression.
The total score ranges from 0 to 30, with higher scores suggesting a higher level of depression symptoms.
|
1st. day 1st. week 3rd months 6th months
|
breast problems between two groups on 1 st week
Time Frame: 1st week
|
breast problem will assesment with breastfeeding problems questionnaire.
number and percent will use to evaluate.
|
1st week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2020
Primary Completion (Actual)
November 20, 2020
Study Completion (Actual)
July 15, 2022
Study Registration Dates
First Submitted
March 1, 2023
First Submitted That Met QC Criteria
March 10, 2023
First Posted (Actual)
March 23, 2023
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 10, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 4-6/16.06.2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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